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The Impact of Nebivolol Versus Metoprolol on Quality of Life

This study has been terminated.
(due to slow enrollment)
Sponsor:
Collaborators:
Forest Laboratories
Lahey Clinic
Information provided by (Responsible Party):
Steven Gabardi, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01441570
First received: September 26, 2011
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

In an open label analysis, nebivolol has been shown to have a positive impact on quality of life in the general hypertensive population. That is, patients treated with nebivolol reported less side effects compared to those treated with metoprolol. Also, more nebivolol treated patients reached normalization of blood pressure. Although there is no data, it is believed that the impact would be similar in renal transplant recipients.

The primary goal of this study is to determine if nebivolol will improve the quality of life measurements of kidney transplant recipients as compared to those treated with metoprolol succinate. This will be measured by comparing the scores of four quality of life questionnaires taken before and after 12 weeks of treatment with study drug. Other aims of this study are to determine if the use of nebivolol is cost-effective in the renal transplant recipient; determine if there is a change in urine protein excretion and renal function with the use of nebivolol; and determine the number of patients that maintain or achieve a target blood pressure of ≤ 120/80 mmHg.


Condition Intervention
Transplant; Failure, Kidney
Hypertension
Drug: Nebivolol
Drug: Metoprolol succinate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Nebivolol Versus Metoprolol on Quality of Life Measures and Cost-effectiveness in Stable Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Primary outcome measure will be the change from the Screening/Enrollment Visit to the End of the Study/Early Termination visit in scores of four quality of life questionnaires.


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate the number of subjects in the nebivolol group that are at goal blood pressure (120/80 mmHg) as compared to those in the metoprolol succinate group.

  • Cost-effectiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate the cost-effectiveness of nebivolol as compared to metoprolol succinate.

  • Urine Protein and calculated GFR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate change in urinary protein excretion and calculated glomerular filtration rate in subjects in the nebivolol group as compared with those in the metoprolol succinate group.


Enrollment: 24
Study Start Date: February 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nebivolol Drug: Nebivolol
Subject will take nebivolol daily for 12 weeks.
Other Name: Bystolic
Active Comparator: Metoprolol Succinate Drug: Metoprolol succinate
Subject will take metoprolol succinate daily for 12 weeks.
Other Name: Toprol XL

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult renal transplant recipients, men and women between 18 and 75 years of age, inclusive.
  • Patients must be > 3 months post-transplant.
  • Patients must have stable renal function (stable renal function will be defined as those patients without infection or hospitalization [for any reason] over the past 30 days, and patients with < 20% change in their serum creatinine over the past 30 days.
  • Patients receiving corticosteroids must be receiving a daily dose of < 7.5 mg of prednisone (or therapeutic equivalents based on glucocorticoid equivalency scale).
  • All eligible patients must be receiving antihypertensive medication management which must include metoprolol tartrate or metoprolol succinate.
  • Patients may be on more than one medication to control their hypertension. Use of any other FDA-approved antihypertensive agent is permitted.
  • All eligible patients will either be at goal blood pressure (<120/80 mmHg) or have Pre-hypertension (<140/90 mmHg) or Stage I hypertension (<160/100 mmHg) at the time of study inclusion.
  • Patients who are able to comprehend and satisfactorily comply with protocol requirements.
  • Patients who signed the written informed consent given prior to entering any study procedure.

Exclusion Criteria:

  • Patients with Stage II/uncontrolled hypertension (>159/99 mmHg).
  • Patients with an easily identifiable etiology for fatigue (i.e. anemia, iron-deficiency, poor sleep patterns, etc.).
  • Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial (i.e. arrhythmia).
  • Patients with any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, hepatic, gastrointestinal or neurological disease (including any form of epilepsy). If there is a history of such disease but the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
  • Patients who are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
  • Patients with any contraindications to beta blocker therapy as listed in the package labeling for both metoprolol succinate and nebivolol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441570

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Brigham and Women's Hospital
Forest Laboratories
Lahey Clinic
Investigators
Principal Investigator: Steven Gabardi, PharmD, FCCP, BCPS Transplant Surgery
  More Information

No publications provided

Responsible Party: Steven Gabardi, Abdominal Organ Transplant Specialist, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01441570     History of Changes
Other Study ID Numbers: 2011P001638
Study First Received: September 26, 2011
Last Updated: July 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
kidney
transplant
hypertension
nebivolol
metoprolol
bystolic
toprol

Additional relevant MeSH terms:
Hypertension
Renal Insufficiency
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Vascular Diseases
Metoprolol
Metoprolol succinate
Nebivolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014